意外接种 HPV 疫苗后孕妇自发性流产的风险。

Risk of Spontaneous Abortion After Inadvertent Human Papillomavirus Vaccination in Pregnancy.

机构信息

HealthPartners Institute, Minneapolis, Minnesota; the Department of Obstetrics, Gynecology, & Reproductive Sciences, Yale University School of Medicine, New Haven, Connecticut; the Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon; the Vaccine Study Center, Kaiser Permanente Northern California, Oakland, and the Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California; the Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado; Marshfield Clinic Research Institute, Marshfield, Wisconsin; Kaiser Permanente Washington Health Research Institute, Seattle, Washington; Harvard Pilgrim Health Care Institute, Boston, Massachusetts; and the Centers for Disease Control and Prevention, Atlanta, Georgia.

出版信息

Obstet Gynecol. 2018 Jul;132(1):35-44. doi: 10.1097/AOG.0000000000002694.

Abstract

OBJECTIVE

To evaluate the risk of spontaneous abortion after quadrivalent human papillomavirus (4vHPV) vaccination before and during pregnancy across seven integrated health systems within the Vaccine Safety Datalink.

METHODS

Within a retrospective observational cohort, we compared risks for spontaneous abortion after 4vHPV in three exposure windows: distal (16-22 weeks before the last menstrual period [LMP]), peripregnancy (within 6 weeks before the LMP), and during pregnancy (LMP through 19 weeks of gestation). Women 12-27 years of age with a pregnancy between 2008 and 2014, with continuous insurance enrollment 8 months before and through pregnancy end, and with a live birth, stillbirth, or spontaneous abortion were included. Pregnancies were identified through validated algorithms. Spontaneous abortions and stillbirths were verified by chart review with spontaneous abortions adjudicated by clinical experts. We excluded multiple gestations, spontaneous abortions before 6 weeks of gestation, and women using medications increasing risk of spontaneous abortion. Spontaneous abortion risk after 4vHPV during pregnancy was compared with distal vaccination using time-dependent covariate Cox models. Spontaneous abortion risk for peripregnancy compared with distal vaccination was evaluated with standard Cox models.

RESULTS

We identified 2,800 pregnancies with 4vHPV exposure in specified risk windows: 919 (33%) distal, 986 (35%) peripregnancy, and 895 (32%) during pregnancy. Mean age was 22.4 years in distal and peripregnancy groups compared with 21.4 years among women vaccinated during pregnancy. Among women with distal 4vHPV exposure, 96 (10.4%) experienced a spontaneous abortion. For peripregnancy and during pregnancy exposures, spontaneous abortions occurred in 110 (11.2%) and 77 (8.6%), respectively. The risk of spontaneous abortion was not increased among women who received 4vHPV during pregnancy (adjusted hazard ratio 1.10, 95% CI 0.81-1.51) or peripregnancy 1.07 (0.81-1.41).

CONCLUSION

Inadvertent 4vHPV exposure during or peripregnancy was not significantly associated with an increased risk of spontaneous abortion.

摘要

目的

在疫苗安全数据链的七个综合卫生系统中,评估四价人乳头瘤病毒(4vHPV)疫苗在妊娠前和妊娠期间接种后自然流产的风险。

方法

在一项回顾性观察性队列研究中,我们比较了 4vHPV 在三个暴露窗口后的自然流产风险:远端(末次月经前 16-22 周)、围孕期(末次月经前 6 周内)和孕期(末次月经至妊娠 19 周)。纳入年龄在 12-27 岁之间、2008 年至 2014 年期间妊娠、连续保险登记 8 个月前至妊娠结束、并分娩活产、死胎或自然流产的女性。妊娠通过验证算法确定。自然流产和死胎通过病历审查进行验证,自然流产由临床专家进行裁决。我们排除了多胎妊娠、妊娠 6 周前的自然流产和使用增加自然流产风险的药物的女性。通过时间依赖协变量 Cox 模型比较孕期接种 4vHPV 后自然流产的风险,并通过标准 Cox 模型评估围孕期与远端接种相比的自然流产风险。

结果

我们在指定的风险窗口中确定了 2800 例有 4vHPV 暴露的妊娠:919 例(33%)远端、986 例(35%)围孕期和 895 例(32%)孕期。与孕期接种的女性相比,远端和围孕期组的平均年龄分别为 22.4 岁和 21.4 岁。在接受远端 4vHPV 暴露的女性中,96 例(10.4%)发生自然流产。在围孕期和孕期暴露中,自然流产分别发生在 110 例(11.2%)和 77 例(8.6%)。孕期或围孕期意外接触 4vHPV 并不会显著增加自然流产的风险(调整后的危险比为 1.10,95%CI 0.81-1.51)或围孕期的 1.07(0.81-1.41)。

结论

妊娠期间或围孕期无意中接触 4vHPV 与自然流产风险增加无关。

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